FOR OFFICE USE ONLY. IACUC PROTOCOL NUMBER: IACUC Approval has been granted for the project described in this document
|
|
- Joan Miller
- 6 years ago
- Views:
Transcription
1 ADMINISTRATIVE COVER SHEET FOR AN APPLICATION TO USE LIVE VERTEBRATE ANIMALS IN FIELD RESEARCH Arkansas Tech University Institutional Animal Care and Use Committee (IACUC) FOR OFFICE USE ONLY IACUC PROTOCOL NUMBER: IACUC Approval has been granted for the project described in this document Original Approval Date: Approval Period: From To Please submit this form electronically as a single.pdf document to the IACUC at IACUC@atu.edu. (Paper submissions will not be accepted). CHECK ONE: 1. TITLE OF PROJECT: New Application 3 Year Renewal - Be sure to include any modifications to procedures when completing the new application. Please provide the previously assigned IACUC protocol number: 2. PRINCIPAL INVESTIGATOR (PI) INFORMATION: (If not ATU Faculty, include an ATU Faculty sponsor, see Question #4) Please indicate how you prefer to be contacted: Fax PI Name: Work Address: Department: Work Phone: FAX #: Emergency phone (after hours) #: Cell #: Address: 3. CO- INVESTIGATOR (CI) INFORMATION: (If not an ATU Faculty, include an ATU Faculty sponsor, see Question #4) Please indicate how you prefer to be contacted: Fax PI Name: Work Address: Department: Work Phone: FAX #: Emergency phone (after hours) #: Cell #: Address: Page 1
2 4. CONTACT PERSON FOR PAPERWORK ISSUES (if other than PI): N/A Please indicate how person prefers to be contacted: Fax Name: Work Address: Department: Work Phone: FAX #: Address: 5. ATU FACULTY SPONSOR: (required if PI is not ATU faculty): N/A Please indicate how person prefers to be contacted: Fax Name: Work Address: Department: Work Phone: FAX #: Address: 6. QUALIFICATIONS AND TRAINING OF PERSONNEL: Please list all personnel** associated with Arkansas Tech University (e.g. formal volunteer, student, faculty, staff) who will be working with or handling live vertebrate animals associated with this protocol: **For each individual, including the PI who is listed above, include a brief descripion of qualifications to be involved in the research. 7. FUNDING (Check all that apply): Intramural Funding: (e.g. Departmental funds, personal funds, various donors/gifts, etc.) Protocols funded by the Department or any non-peer reviewed source require Department Chair signature (Section 9 in this application). Extramural Funding: Please provide the following information for extramural funding that has been or is expected to be funded (e.g. fundable score, JIT, IACUC congruency approval required prior to proposal submission, etc). AGENCY/ SPONSOR PI OF AWARD AGENCY AWARD NUMBER IRES PROPOSAL NUMBER TITLE Page 2
3 APPLICATION TO USE LIVE VETEBRATE ANIMALS IN FIELD RESEARCH Arkansas Tech University Institutional Animal Care and Use Committee OFFICE USE ONLY Protocol Number: Approval Period: From To PI NAME: DEPT.: WORK PHONE: TYPE OF PROJECT (please check one): Research Teaching/training Collection/Banking Behavioral Manipulation All sections of the application must be completed within the form field provided. If a specific section of this application does not apply to your project, please indicate that it is not applicable (NA). If attachments are necessary to provide a response to a specific section, the attachment must be clearly referenced under the appropriate section and the section number noted on the attachment. SECTION 1: RELEVANCE OF RESEARCH Provide a brief synopsis of the project and of its overall objectives and intended benefits to humans, animals and/or the advancement of scientific knowledge. This section should be understandable to a general reader at an 8 th grade level. Page 3
4 SECTION 2: ANIMALS REQUESTED 1) Please list what taxonomic grouping (species if applicable) of vertebrate animals or species will be involved in the study: 2) Please indicate, if applicable, the number of animals listed on the Permit: ( If nothing is listed on the permit, only then please continue on to question #3) 3) Given time constraints in the field, logistics, and other issues (weather, etc.), what is the maximum number of target species that you could conceivably use in the study? (Please note that at annual report the actual number of animals collected and species name must be provided to the IACUC.) 4) Which of the following USDA pain categories applies to the procedures done on animals in your study? B animals collected and bred/held as part of the project C procedures will cause no (or minimal) pain or distress (e.g. injections, blood sampling, tattooing) D procedures involve pain or distress but anesthetics, analgesic or tranquilizing drugs are used E procedures involve pain or distress and no anesthetic, analgesic or tranquilizing drugs can be used (e.g. leg hold trap) If any category E procedures will be performed, provide the approximate number and group name: If more than one category applies please describe/explain: 5) Please provide photocopies of all current permits that authorize the proposed field activity. If current permits are not available, previously issued permits or a copy of the application for the current permit may be submitted temporarily in order to demonstrate concept. Up to date permits must be filed with the IACUC upon receipt in order to be compliant with regulations on animal use numbers. I have attached complete/full copies of all current permits I have attached previously issued permits or a copy of the application for a current permit and will file up to date permits with the IACUC when received Permits do not apply: If permits do not apply to your project, please explain/describe. If permits are not required, if possible, please provide documentation to that effect such as a copy of the regulatory statute or a letter from the appropriate law enforcement agency. Please note additional information may be required for studies that do not require permits. 6) I confirm that at annual review of this project, a copy of my permit annual report will be provided if applicable or a list of each species used in the study and the exact number of individuals will be submitted to the IACUC. 7) I confirm I will abide by state and federal regulations and any local requirements. This includes, but is not limited to, the USDA, FDA, USFWS and the DOT. Page 4
5 SECTION 3: JUSTIFICATION FOR SPECIAL CIRCUMSTANCES N/A If your project involves (1) USDA Category E Procedures, or (2) Death as an Endpoint (i.e. lethality is used as the experimental endpoint rather than euthanasia), or endpoints involving severe morbidity or impairment, strong written scientific justification with particular attention to significance, necessity, and potential benefits of the research is required below: SECTION 4: JUSTIFICATION FOR THE USE OF ANIMALS a) Provide the rationale for the use of live vertebrate animals in this project: b) Explain the scientific rationale for the choice of each species or other taxonomic grouping: c) Explain why the estimated number of animals is necessary (e.g. sample must include ranges of age/stage, sexes, geographic variation, etc.) Page 5
6 SECTION 5: PROCEDURES/ACTIVITIES TO BE DONE ON LIVE VERTEBRATE ANIMALS Which of the following activities will occur to live animals in the field? If checked, answer follow-up questions in Section 6: Capture, other than via trap Trapping Tagging or marking Collection via noxious event (includes gunshot, poison, snap trap, etc.) Euthanasia, other than via lethal event Other SECTION 6: DESCRIPTION OF PROCEDURES/ACTIVITIES Capture, other than via trap: Please describe capture methods (i.e. hand or hand-held noose, net, tongs): Will live animals be brought into Arkansas Tech University? No Yes If YES, please answer the following questions: a) describe what will be done to the animals while at ATU: b) where will the animals be held? c) how long will live animals remain at ATU? d) if animals are euthanized, please outline the process including euthanasia method, dose and route of administration: e) identify transport methods including information regarding maintaining appropriate environment, and food and water sources if applicable: Will animals be housed at Arkansas Tech University longer than 12 hours? No Yes If YES, please provide the following information: a) Who in Veterinary Clinical Services has been contacted to discuss housing and care of the animals? b) Where will the animals be housed? a. Farm Facility: Building: Room number: b. Laboratory Housing: Building: Room number: Will venomous or otherwise dangerous live vertebrate animals be brought into Arkansas Tech University? No Yes If YES, please address the following issues: a) identify the poisonous species: b) identify the venom or poison if known: c) is venom or poison part of the research? d) indicate where emergency anti-venom sources will be maintained: e) describe emergency transportation of anti-venom: Please note that additional information may be required by the IACUC prior to approval. Page 6
7 Non-lethal Trapping: Please indicate the type of trap: Sticky boards Sherman Havahart Mist net Other; please describe: What is the maximum time an animal could spend in a trap before discovery? Please explain/justify. How will trapping non-target species be avoided? Indicate the fate of any trapped non-target species: What will be the fate of any animals wounded in the traps? Tagging or marking: Please indicate the type of tag including the make and model as well as manufacturer (including coded wire tags, bands, ear tags, pit tags, Floy fish tags, sterile beads, etc.): If non-tag marking is used, please describe the method. Fin clip Toe clip Belly scale clip Tattoo Stains/dyes Shell etching Other; please describe: If marking involves cutting or piercing skin, please describe any antiseptic precautions to be taken and/or pain management: Page 7
8 Euthanasia via noxious event (includes gunshot, rotenone, snap trap, etc.): Please describe the noxious event in detail and provide indications of relevant permits and safety precautions: Describe how killing non-target species will be avoided: Describe what will happen to any animals wounded, but not killed. Euthanasia, other than via noxious event: What euthanasia technique will be used? Please indicate the method including dosages: **Please be reminded that many drugs, controlled substances, and some other products are highly regulated materials, and may require permits or special licenses for lawful transportation across state lines or into other countries. Investigators are responsible for ensuring the lawful transport of all of their research materials to avoid legal action up to and including capital punishment.** Note that euthanasia techniques must comply with the AVMA Guidelines on Euthanasia and/or the Arkansas Tech University Policies on euthanasia. If the required technique does not, please provide scientific rationale for deviation. Other: Please describe/explain. Page 8
9 SECTION 7: OTHER HAZARDS How will you protect your safety during animal collection? Will your work involve other hazardous materials, objects, equipment or activities? If so, please list. A Request to Use Hazardous Agents form must also be submitted for all hazardous agents. SECTION 9: DEPARTMENT APPROVAL Required only if the animals will be used in teaching or training or if the animal research will be supported by departmental or non peer-reviewed funding. The Department Chair must read the protocol and sign below indicating department approval before IACUC approval may be granted. Note: If the Department Chair is also an investigator on the protocol, this approval must be obtained from the next highest level of administrative authority not involved in the project. I have read the Application to Use Animals, and find this research to be appropriate in design and that the investigator (or faculty sponsor) is competent to perform (or supervise) this study. My signature below denotes departmental approval of this study as submitted. Typed Name Signature Date Signed Department Chair Department Chair Page 9
10 INVESTIGATOR S ASSURANCE For the Arkansas Tech University Institutional Animal Care and Use Committee (IACUC) By virtue of submitting this application, I, the Primary Investigator, ensure the following: 1. I agree to abide by PHS policy, USDA Regulations, the National Research Council Guide for the Care and Use of Laboratory Animals, all federal regulations, and policies of Arkansas Tech University governing the use of animals in research, teaching and testing. 2. If live vertebrate animals will be returned to Arkansas Tech University I will permit emergency veterinary intervention, even if it could compromise my experiments, for animals showing evidence of pain or illness not addressed specifically in the approved protocol, in addition to appropriate veterinary care as prescribed for individual species. I understand that it is my responsibility to provide current and updated emergency contact information if veterinary intervention will compromise my experiments. 3. I declare that all personnel having direct live animal contact on this project, including myself, have been or will be trained in humane and scientifically acceptable procedures for animal handling, procedural techniques, administration of anesthesia, analgesia and euthanasia to be used in this project, and all are aware of the hazards involving the use of live animals and tissues. Personnel will be allowed adequate time to obtain training necessary for this project. 4. I ensure that all personnel involved in this project will be informed of the procedures outlined in the protocol. 5. I certify that the information provided within this application is accurate to the best of my knowledge. I also understand that should I use the project described in this application as a basis for a proposal for funding (either intramural or extramural), it is my responsibility to ensure that the description of animal use in such funding proposal is identical in principle to that contained in this application. 6. I certify that all Arkansas Tech University personnel in this project will attend the mandatory IACUC Orientation. 7. I am aware that the use of hazardous agents in animals may only be initiated after approval from IACUC. CONSIDERATION OF UNNECESSARY DUPLICATION: 8. I certify that I have consulted the following sources and, to the best of my knowledge, the experiments described in this protocol do not unnecessarily duplicate previous experiments or unnecessarily use animals (check all applicable sources): National Agricultural Library Library of Congress Medline Other (Please specify): Zoological record/biosis Page 10
Vertebrate Animal Use Protocol for Research or Testing
AUP #: ORC USE ONLY Vertebrate Animal Use Protocol for Research or Testing Date Received: Instructions and Researcher Certifications (Failure to follow may result in a delay in processing) Complete this
More informationList the names of all students authorized to conduct procedures involving animals under this proposal
July 2013 COLORADO COMMUNITY COLLEGE SYSTEM ANIMAL STUDY PROPOSAL PLEASE TYPE A. ADMINISTRATIVE DATA Leave Blank Proposal #: Approval Date: Expiration Date: College Department: Principal Student Investigator:
More informationANIMAL USE PROPOSAL BREEDING COLONY
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE Graduate Science Research Center, Suite 102 803/777-8106 Fax 803/777-2849 ANIMAL USE PROPOSAL BREEDING COLONY IACUC Approval Number Date Approved For Office
More informationAmendment to Vertebrate Animal Use Protocol for Research, Testing, or Teaching
AUP #: Date Received: ORC USE ONLY Amendment to Vertebrate Animal Use Protocol for Research, Testing, or Teaching Instructions and Certifications (Failure to follow may result in a delay in processing)
More information(Requires prior approval by an Institutional Review Board (IRB); see full text of the rules.)
: Project Title: 1. I have reviewed the Intel ISEF Rules and Guidelines. 2. I have reviewed the student s completed Student Checklist (1A) and Research Plan/Project Summary. 3. I have worked with the student
More informationChecklist for Adult Sponsor (1) This completed form is required for ALL projects.
Checklist for Adult Sponsor (1) This completed form is required for ALL projects. To be completed by the Adult Sponsor in collaboration with the student researcher(s): : Project Title: 1. o I have reviewed
More informationGeneral Tips For IACUC Protocol Submissions. Diana Li IACUC Senior Analyst University of California, Irvine
General Tips For IACUC Protocol Submissions Diana Li IACUC Senior Analyst University of California, Irvine Getting Started with Animal Research at UCI Using animals in research is a privilege expectation
More informationChecklist for Adult Sponsor (1) This completed form is required for ALL projects.
Checklist for Adult Sponsor (1) This completed form is required for ALL projects. To be completed by the Adult Sponsor in collaboration with the student researcher(s): : Project Title: 1. o I have reviewed
More informationUniversity Council on Animal Care
Policy: Animal Use Protocols Category: Administration Subject: The generation, review and approval of Animal Use Protocols Approving Authority: University Council on Animal Care Responsible Office: Animal
More information"I'm a Field Biologist. Must I submit my protocol for IACUC review?"
Field Studies "I'm a Field Biologist. Must I submit my protocol for IACUC review?" Federal regulations and Guidelines dealing with animal welfare focus mainly on biomedical and behavioral research, teaching,
More informationREGULATORY ISSUES: HOW TO APPLY FOR AN IND. Penny Jester and Maaike Everts
REGULATORY ISSUES: HOW TO APPLY FOR AN IND Penny Jester and Maaike Everts Outline 2 What is the purpose of an IND? What types of INDs are there? When do you need one? How do you apply for one? How do you
More informationType: Embedded within the selected substance, indicated when creating the substance.
Overview: Substance Table: Each procedure will include a substance table, either on the main page of the procedure (immediately after selecting the procedure type), embedded elsewhere within a procedure,
More informationInstitutional Review Board for Use of Human and Animal Subjects in Research OIT
OREGON INSTITUTE OF TECHNOLOGY Institutional Review Board for Use of Human and Animal Subjects in Research Introduction No person in the United States should be enrolled in research without the twin protections
More informationBasic Training Module for Research Personnel
Basic Training Module for Research Personnel Welcome to the IU Bloomington (IUB) Training Program in Laboratory Animal Care and Use. This Basic Module for Research Personnel is required for all faculty,
More informationRemote Production of Custom Antibodies
Remote Production of Custom Antibodies 372.1 Policy: The purchase of custom polyclonal and monoclonal antibodies requires the submission and approval of an animal use protocol through the Institutional
More informationSection A Definitions
Guidelines for Surgical Procedures in Rodents, Birds, and Cold-Blooded Vertebrates The University of Texas at Austin Institutional Animal Care and Use Committee These guidelines have been written to assist
More informationJawatankuasa Penjagaan dan Penggunaan Haiwan Institusi USM (JKPPH USM) USM Institutional Animal Care and Use Committee (USM IACUC)
Jawatankuasa Penjagaan dan Penggunaan Haiwan Institusi USM (JKPPH USM) USM Institutional Animal Care and Use Committee (USM IACUC) CHECKLIST OF ANIMAL ETHICS APPLICATION, PLEASE TICK ( ) IN THE BOX BELOW
More informationGuideline to Assist in Completing the Institutional Animal Care and Use Committee (IACUC) Protocol for a UC Davis VMTH Clinical Trial
VETERINARY MEDICINE Veterinary Center for Clinical Trials Guideline to Assist in Completing the Institutional Animal Care and Use Committee (IACUC) Protocol for a UC Davis VMTH Clinical Trial Purpose:
More informationInitial Reporting of Animal Welfare Concern to the Institution
IACUC POLICY INVESTIGATING ANIMAL WELFARE CONCERNS & NONCOMPLIANT ACTIVITIES To ensure the humane care and treatment of animals used in research, teaching, and testing, the Drexel University Institutional
More informationOffice for Human Subject Protection. University of Rochester
POLICY 1. Purpose Outline the responsibilities and regulatory requirements when conducting human subject research that involves the use of drugs, agents, biological products, or nutritional products (e.g.,
More informationANIMAL UTILIZATION PROJECT PROPOSAL
AUPP # UNIVERSITY OF WINDSOR ANIMAL CARE COMMITTEE ANIMAL UTILIZATION PROJECT PROPOSAL All research and/or teaching projects conducted at the University of Windsor with live non-human vertebrate animals
More informationPolicies Concerning Survival Surgery of Mice
Policies Concerning Survival Surgery of Mice Date approved: October 25, 2016 Purpose This document details the minimum standards for survival (recovery) surgery in all laboratory rodent species. Responsibility
More informationInvestigator Manual. Human Subjects Protection Program
Human Subjects Protection Program HRP-103, Revised June 1, 2015 HRP-103 06/01/2015 2 of 33 Table of Contents Scope... 3 What is the purpose of this manual?... 3 What is Human Research?... 3 What is the
More informationOBTAINING A SMALLTOOTH SAWFISH SCIENTIFIC RESEARCH OR ENHANCEMENT PERMIT: Navigating the Process
OBTAINING A SMALLTOOTH SAWFISH SCIENTIFIC RESEARCH OR ENHANCEMENT PERMIT: Navigating the Process Jennifer F. Jefferies and David O Brien Office of Protected Resources Prohibitions of the ESA Taking a listed
More informationPRINCIPAL INVESTIGATOR MANUAL
PRINCIPAL INVESTIGATOR MANUAL Office of Animal Welfare Assurance Table of Contents I. INTRODUCTION 4 II. SOM ANIMAL CARE & USE PROGRAM 4 III. FEDERAL MANDATES / REGULATIONS 5 IV. INSTITUTIONAL ANIMAL CARE
More informationLast Name First Name M.I. Address Home Phone Home Address City State Zip Code Grade Age Gender: M. Parent/Guardian Signature:
Delaware Technical Community College 23 rd Annual New Castle County Science Fair Application for New Castle County Students Type or Print neatly Unreadable applications will not be processed. Student Information
More informationUniversity of California, Berkeley Animal Care and Use Program
Version: 3 Effective Date: July 1, 2017 POLICY ON PROTOCOL REVIEW Supercedes Document Dated: February 8, 2017 I. Background The Public Health Service (PHS) Policy as well as the US Department of Agriculture
More informationConsideration of Alternatives to the Use of Live Animals For Research and Teaching
Division of Laboratory Animal Resources Consideration of Alternatives to the Use of Live Animals For Research and Teaching From the ETSU Animal Study Protocol form: The search for alternatives refers to
More informationARIZONA STATE UNIVERSITY INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) POLICIES AND PROCEDURES MANUAL. July 27, 2017
ARIZONA STATE UNIVERSITY INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) POLICIES AND PROCEDURES MANUAL July 27, 2017 Tamara Deuser Associate Vice President Animal Care and Use Program Institutional
More informationMANUAL FOR VERTEBRATE ANIMAL RESEARCH
The University of Vermont Institutional Animal Care and Use Committee Serving The University of Vermont http://www.uvm.edu/iacuc/ MANUAL FOR VERTEBRATE ANIMAL RESEARCH Research Protections Office 213 Waterman
More informationVertebrate Animal Research
Vertebrate Animal Research CREST-Jane Goodall Science Symposium Supplemental Guidelines & Requirements for your ISEF Research Plan rev. Aug 2016 The use of animals in your project is a privilege that carries
More informationBIOSAFETY REGISTRATION FORM
BRF 5/2015 Page 1 of 5 COMMITTEE USE ONLY 1. PERSONNEL TEMPLE UNIVERSITY Office of the Vice Provost for Research Division of Research Compliance Institutional Biosafety Committee Tel: (215) 707-9741, Fax:
More informationPosition Summary ANALYST II. Non-Exempt. Uncovered CLOSEOUT ANALYST. Ahmad Hakim-Elahi
Page 1 of 5 Position Summary Employee Details Employee First Name: Employee Last Name: Employee ID: Classification Payroll Title: ANALYST II Payroll Title Code: 7235 Job Group: Overtime Eligible: (FLSA)
More informationInstitutional Biosafety Committee
Northern Illinois University Institutional Biosafety Committee Policy Office of Research Compliance, Integrity and Safety 2017 Northern Illinois University Institutional Biosafety Committee Purpose...
More informationINSTRUCTION MANUAL IACUC ELECTRONIC APPLICATION. UNMC/UNO Institutional Animal Care and Use Committee VOLUME
UNMC/UNO Institutional Animal Care and Use Committee VOLUME 1 IACUC ELECTRONIC APPLICATION INSTRUCTION MANUAL 987830 Nebraska Medical Center Omaha, NE 68198-7830 (402) 559-6046 www.unmc.edu/iacuc iacucora@unmc.edu
More informationInstitutional Animal Care and Use Committee Policies and Procedures Manual. Office of Research and Economic Development University of Wyoming
Page 1 of 51 Institutional Animal Care and Use Committee Policies and Procedures Manual Office of Research and Economic Development University of Wyoming Office of Research and Economic Development Dept.
More informationCOMMITTEE USE ONLY IBC REGISTRATION
BRF September 2016 Page 1 of 6 COMMITTEE USE ONLY IBC REGISTRATION # ASSOCIATED ACUP/IRB# Research Integrity and Compliance Institutional Biosafety Committee APPROVAL BIOSAFETY REGISTRATION FORM Tel: (215)
More informationEmbryonic Stem Cell Research Oversight Committee (ESCRO) Application Form
Embryonic Stem Cell Research Oversight Committee (ESCRO) Application Form A. Demographic Information Date of Submission: Reason for Submission: New Project Response to Comments Reconsideration Disapproval
More informationOverview of ISEF Forms
Overview of ISEF Forms The Intel ISEF forms constitute written documentation of what will occur, or in some cases, has already occurred, in a research project. They are designed to provide the information
More informationINTERNATIONAL SCIENCE AND ENGINEERING FAIR Rules and Guidelines
INTERNATIONAL SCIENCE AND ENGINEERING FAIR Rules and Guidelines Adult Roles and Responsibilities n Adult Sponsor n Designated Supervisor n Qualified Scientist n IRB n SRC Adult Sponsor n Oversees project
More informationAnimal/Human Subjects Research at DARPA
Animal/Human Subjects Research at DARPA Lisa Mattocks STO ADPM/ASR and HSR Action Officer INTERCEPT Proposers Day April 28, 2016 What is an Animal? According to the DoD, an animal IS A living or dead vertebrate
More informationXAVIER UNIVERSITY OF LOUISIANA ANIMAL RESOURCE FACILITY
XAVIER UNIVERSITY OF LOUISIANA ANIMAL RESOURCE FACILITY Institutional Animal Care and Use Committee Policies and Procedures Manual Xavier University of Louisiana Animal Resource Facility 1 Drexel Drive
More informationCITI Certificates
CITI Certificates 2017-2018 Adu.Research.Office@adu.edu Room CC340 Table of Contents Human Subjects Research... 1 Biomedical Research - Basic/Refresher - Basic Course:... 1 Required Courses:... 1 Human
More informationIII. Risk Assessment and Research Protocols
III. Risk Assessment and Research Protocols III.1. Risk Assessment New research or development initiatives are evaluated by the Principal Investigator in the early planning stages for the hazards that
More informationInstitutional Animal Care and Use (IACUC) Standard Operating Procedures (SOP) Institutional Review Board (IRB) Member Resources
Institutional Review Board (IRB) Member Resources Institutional Animal Care and Use (IACUC) Standard Operating Procedures (SOP) Texas A&M University Corpus Christi Institutional Animal Care and Use Committee
More informationP.O. BOX 489, ORTING, WA Phone: (360) FAX (360)
CITY OF ORTING APPLICATION FOR EMPLOYMENT P.O. BOX 489, ORTING, WA 98360 Phone: (360) 893-2219 - FAX (360) 893-6809 EQUAL OPPORTUNITY: The City of Orting, Washington is an equal opportunity employer. We
More informationOffice of Graduate and Professional Studies
Reset Form Print Form Office of Graduate and Professional Studies PROPOSAL APPROVAL FORM FOR THESIS, DISSERTATION, OR RECORD OF STUDY Full proposal should be attached This form must be approved by OGAPS
More informationNot My Study Challenges of Clinical Trial Disclosure at an Academic Medical Center
Not My Study Challenges of Clinical Trial Disclosure at an Academic Medical Center Office of Research Compliance and Quality Assurance Yolanda P. Davis Sr. Research Compliance Officer Author: Yolanda P.
More informationCopyright. Jeremiah J. Kelly (2015). All rights reserved. Further dissemination without express written consent strictly prohibited.
Statutory Framework for Biologics Drugs Investigational Use Application IND Pre-Market Approval Applications 505(b)(1) NDA 505(b)(2) NDA 505(j) ANDA Over-the-Counter (OTC) Non- Rx Drugs Monograph Biologics
More informationMaintaining your Investigational Device Exemption (IDE) with the FDA: Keys for Success. Jenna Stump, MS, CCRP Clinical Research Regulatory Specialist
Maintaining your Investigational Device Exemption (IDE) with the FDA: Keys for Success Jenna Stump, MS, CCRP Clinical Research Regulatory Specialist Agenda How an investigator should prepare and submit
More informationSTANDARD OPERATING PROCEDURES DIVISION OF COMPARATIVE MEDICINE UNIVERSITY OF SOUTH FLORIDA
STANDARD OPERATING PROCEDURES DIVISION OF COMPARATIVE MEDICINE UNIVERSITY OF SOUTH FLORIDA SOP#: 014.5 Date Issued: 11/00 Date Revised: 8/15 Page 1 of 5 TITLE: SCOPE: RESPONSIBILITY: PURPOSE: Research
More informationPre-Screening revised checklist for BA/BE NOC for Export Purpose
Pre-Screening revised checklist for BA/BE NOC for Export Purpose O/o Drugs Controller General (India) Directorate General of Health Services FDA Bhawan, New Delhi (With effective from 25 th April 2014)
More informationStudy Start-Up SS STANDARD OPERATING PROCEDURE FOR Investigator Selection
Effective date of version: April 01, 2012 Study Start-Up SS 202.00 STANDARD OPERATING PROCEDURE FOR Investigator Selection Approval: Nancy M. Paris, MS, FACHE President and CEO 08 March 2012 (Signature
More informationRailroad Commission of Texas Mentor Protégé Program
Railroad Commission of Texas Mentor Protégé Program December 3, 2002 1 1.0 Description The Railroad Commission of Texas Mentor/Protégé Program is developed in accordance with Government Code 2161.065 and
More informationLast Name: First Name: Middle Initial: If you are under age 18, can you furnish a work permit? YES NO
We are a Sustainably Oriented, SHARP Safety Graduate and an Equal Opportunity Employer Position you are applying for: Date: Email Address: Last Name: First Name: Middle Initial: Other Names Used (Maiden
More informationGuidance for Industry and FDA Staff Procedures for Handling Post-Approval Studies Imposed by PMA Order
Guidance for Industry and FDA Staff Procedures for Handling Post-Approval Studies Imposed by PMA Order Document issued on: [Level 2, June 15, 2009] This guidance supersedes the document issued under this
More informationAUBURN UNIVERSITY ANIMAL RESOURCES PROGRAM CORE TRAINING MANUAL. Revised February 2013
AUBURN UNIVERSITY ANIMAL RESOURCES PROGRAM CORE TRAINING MANUAL Revised Sections A, D, and E Applicable items in Sections G and H Section F Sections B and C should be read by Principal Investigators, Co-investigators,
More informationSCIENTIFIC AND INSTITUTIONAL REVIEW
SCIENTIFIC AND INSTITUTIONAL REVIEW Elementary & Junior Division (grades 5-8) Projects Only The Arizona Science and Engineering Fair (AzSEF) follows all Intel International Science and Engineering Fair
More informationCANCER CENTER SCIENTIFIC REVIEW COMMITTEE
CANCER CENTER SCIENTIFIC REVIEW COMMITTEE The Clinical Scientific Review Committee (SRC) at The Medical College of Wisconsin Cancer Center plays a vital role in protocol review and monitoring to ensure
More informationGOOD LABORATORY PRACTICE (GLP)
GOOD LABORATORY PRACTICE (GLP) Series Catalog CITI Program s GLP series provides an overview of how nonclinical laboratory studies should be planned, performed, monitored, recorded, reported, and archived
More informationAPPLICATION INSTRUCTIONS INSTITUTIONAL REVIEW BOARD. Revised January 2010 Page 1
APPLICATION INSTRUCTIONS INSTITUTIONAL REVIEW BOARD Revised January 2010 Page 1 The IRB Proposal Includes: 1. All documents, other than the informed consent form, should be understandable to an informed
More information3.1. Overall Principal Investigator (PI), who holds the IND and is the Sponsor.
SOP #: RCO-100 Page: 1 of 11 1. POLICY STATEMENT: An Overall Principal Investigator (PI) who holds an Investigational New Drug Application (IND) and who is the Sponsor of the research has additional responsibilities
More information1. Checklist for Grant of permission to manufacture/import of Bulk Drug already approved in the country
1. Checklist for Grant of permission to manufacture/import of Bulk Drug already approved in the country S no 1. Name of Applicant with address 2. Name of Drug 3. Therapeutic Class 4. Date of Approval Documents
More informationConflict of Interest Disclosure Form
Fill out this paper form only if you are not required to complete the University s on-line outside interest disclosure form (M-Inform) and have a real, perceived or potential conflict of interest. Please
More informationMEDICINES CONTROL COUNCIL
ectd VALIDATION and TECHNICAL VERIFICATION MEDICINES CONTROL COUNCIL VALIDATION TEMPLATE FOR APPLICATIONS FOR REGISTRATION IN ectd format The Validation Template is to be used on receipt of an application
More informationInstitutional Animal Care and Use (IACUC) General Operations Manual (GOM)
Institutional Animal Care and Use (IACUC) General Operations Manual (GOM) Version 7 5/9/2017 Tarleton State University Institutional Animal Care and Use Committee (IACUC) General Operations Manual (GOM)
More informationGUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN MAKING AN ASSESSMENT OF CLINICAL INVESTIGATION NOTIFICATION
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Cosmetics and Medical Devices MEDDEV 2.7.2 December 2008 GUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN
More informationApplication form UNIVERSITY OF NOTTINGHAM MEDICAL SCHOOL ETHICS COMMITTEE
Application form UNIVERSITY OF NOTTINGHAM MEDICAL SCHOOL ETHICS COMMITTEE In completing this form please refer to the attached Notes of Guidance Application for approval of all studies involving Healthy
More informationRESEARCH ASSOCIATE (RA), SENIOR RESEARCH ASSOCIATE (SRA)
RESEARCH ASSOCIATE (RA), SENIOR RESEARCH ASSOCIATE (SRA) AND RESEARCH SCIENTIST (RS) POLICY AND PROCEDURES All questions and materials should be directed to: Office of Faculty Affairs and Human Resources
More informationBEDFORD PARK POLICE DEPARTMENT 6701 SOUTH ARCHER AVENUE BEDFORD PARK ILLINOIS PHONE FAX
Selection Process Testing Order Candidates must successfully complete each test before advancing to the next phase of the selection process. The entire selection process may take several months. SELECTION
More informationGLOBAL HEALTH SUPPLY CHAIN QUALITY ASSURANCE
GLOBAL HEALTH SUPPLY CHAIN QUALITY ASSURANCE Medical Device Product Questionnaire This questionnaire is used to collect information from vendors with regards to medical devices that fall in any of the
More informationApplicability of US Regulations to Canadian Research
Applicability of US Regulations to Canadian Research Mary Kate Needler Capital District Health Authority Halifax, Nova Scotia, Canada N2 Stakeholder Meeting August 18, 2014 MK s Conventions: 1. US Regulation
More informationThe Children s Hospital of Philadelphia Committees for the Protection of Human Subjects Policies and Procedures Determination of IND/IDE Requirement
Page: 1 of 8 I. PURPOSE II. III. IV. The purpose of this Standard Operating Procedure is to delineate when an investigator must obtain an Investigational New Drug (IND) or Investigational Device Exemption
More informationSUBRECIPIENT MONITORING GUIDE
SUBRECIPIENT MONITORING GUIDE Introduction The following Roles and Responsibilities Chart serves as a reference for University of Arizona Principal Investigators and designated department personnel (Business/Finance
More informationGuide to Scientific and Regulatory Advice for GXP activities
Guide to Scientific and Regulatory Advice for GXP activities ADV-G0019-1 7 OCTOBER 2017 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only.
More informationUsing Your Prescription. Drug Program. Answers to important questions about retail pharmacy and mail order purchasing
Using Your Prescription Drug Program Answers to important questions about retail pharmacy and mail order purchasing Welcome! We know you re going to enjoy the many advantages of your prescription drug
More informationSECTION I CITIZENSHIP: CITIZENSHIP: SECTION II
APPLICATION FOR INSTITUTIONAL BIOSAFETY COMMITTEE REVIEW AND APPROVAL South Dakota School of Mines and Technology (Protocol Submission Form) This form must be submitted for ALL research or teaching activities
More informationFRANCHE COMMUNITY PRIMARY SCHOOL & Policies & Procedures
Title: Storage and Administering of Medicines Method Statement & Policy 2018-19 DOCUMENT MANAGEMENT This document was adopted at the PAW Committee Meeting on 24 th January 2018 This document is subject
More informationInstitutional Review Board Compliance Elizabeth City State University
Institutional Review Board Compliance Elizabeth City State University Michelle Moore, MBA Research Compliance Officer/IRB Administrator Office of Sponsored Programs, Contracts & Grants 110 McLendon Hall
More informationHuman Research Protection Program. Investigator Manual
Human Research Protection Program Revised July 7, 2014 HRP-910 7/7/2014 2 of 10 Table of Contents What is the purpose of this manual?... 3 What is Human Research?... 3 What is the Human Research Protection
More information18.0 INSTITUTIONAL BIOSAFETY COMMITTEE
18.0 INSTITUTIONAL BIOSAFETY COMMITTEE 18.1 INTRODUCTION... 1 18.2 BIOLOGICAL SAFETY COMMITTEE SCOPE AND MISSION STATEMENT... 1 18.3 DEFINITION OF A BIOLOGICAL AGENT... 2 18.4 REVIEW CLASSIFICATION...
More informationNORTHEASTERN UNIVERSITY INSTITUTIONAL BIOSAFETY COMMITTEE CHARTER
NORTHEASTERN UNIVERSITY INSTITUTIONAL BIOSAFETY COMMITTEE CHARTER Date Approved: 7/11/17 Last Revision Date: 7/11/17 Introduction I. Purpose Northeastern University s (NU) Institutional Biosafety Committee
More informationMARKET BEEF RECORD BOOK WOOD COUNTY 4-H/FFA MARKET ANIMAL RECORD BOOK RULES
MARKET BEEF RECORD BOOK WOOD COUNTY 4-H/FFA MARKET ANIMAL RECORD BOOK RULES The Market Animal Drug History page must be completed and turned in at the final weigh-in or your animal will not be accepted
More informationMODERATOR APPLICATION FORM
MODERATOR APPLICATION FORM 1. PURPOSE This Guide has been developed to assist constituent moderators to prepare for and apply for registration with the SASSETA ETQA. The SASSETA registers assessors and
More informationMARKET HOG RECORD BOOK WOOD COUNTY 4-H/FFA MARKET ANIMAL RECORD BOOK RULES
MARKET HOG RECORD BOOK WOOD COUNTY 4-H/FFA MARKET ANIMAL RECORD BOOK RULES The Market Animal Drug History page must be completed and turned in at the final weigh-in or your animal will not be accepted
More informationILLINOIS INSTITUTE OF TECHNOLOGY SAFETY POLICY COMMITTEE. Contractor Safety
ILLINOIS INSTITUTE OF TECHNOLOGY SAFETY POLICY COMMITTEE Contractor Safety Approved: October 10, 2005 Reviewed and Modified: October 17, 2016 1 TABLE OF CONTENTS Section Page 1. Purpose...1 2. Scope...
More informationFrequently Asked Questions - PHS Policy on Humane Care and Use of Laboratory Animals - Off... Page 1 of 19 Glossary & Acronyms Frequently Asked Questions PHS Policy on Humane Care and Use of Laboratory
More informationDr. David D. Lee, Provost and VP for Academic Affairs
POLICY & PROCEDURE DOCUMENT NUMBER: 2.7000 SECTION: TITLE: Research Institutional Biosafety Committee Policy DATE: November 6, 2017 Authorized by: Dr. David D. Lee, Provost and VP for Academic Affairs
More informationSource Documents and Regulatory Binders October 6, 2016
Source Documents and Regulatory Binders October 6, 2016 Lisa Wilson, Regulatory Lead, Clinical Trials Office and Mark Alger, CRC, Clinical Trials Office Essential Documents AKA: the stuff in the Reg Binder
More informationEMPLOYMENT APPLICATION
Name: Applying For: Preferred Location: Date: EMPLOYMENT APPLICATION Please complete all items even though the information may be included on your resume or other documents. If a section does not apply,
More information2016 Rules and Guidelines
2016 Rules and Guidelines Adult roles and responsibilities Adult Sponsor Qualified Scientist Designated Supervisor Institutional Review Board (IRB) Scientific Review Committee (SRC) Adult sponsor Oversees
More informationTOPICS TOPICS. Navigating NIH 2016 Policy Changes for Grant Applications and Availability of Proposal Resources
Navigating NIH 2016 Policy Changes for Grant Applications and Availability of Proposal Resources John Ivy, Ph.D. Sr. Research Development Officer johnivy@tamu.edu Christina Papke, Ph.D. Research Development
More informationNOTICE OF JOB OPENING. CUSTOMER SERVICE REPRESENTATIVE-OFFICE (2 Part-Time Positions Available)
NOTICE OF JOB OPENING CUSTOMER SERVICE REPRESENTATIVE-OFFICE (2 Part-Time Positions Available) Opening Date: February 10, 2015 Classification: Grade 5 Non-Exempt ($17.65 per hour-entry) Closing Date: February
More informationStandard Operating Procedures Guidelines for Good Clinical Practice
SOP # CRSC-105 Effective Date 10-22-2013 Version # 1 Version Date 7-30-2013 Standard Operating Procedures Guidelines for Good Clinical Practice Purpose: This SOP outlines the steps required to follow FDA
More informationPOSITION POSTING INTERMITTENT VEHICLE OPERATOR AIDE. 7:00 a.m. to 9:00 a.m. and 2:30 p.m. to 4:30 p.m., Monday through Friday, as required
POSITION POSTING INTERMITTENT VEHICLE OPERATOR AIDE REGULAR HOURS OF WORK: IMMEDIATE SUPERVISOR: 7:00 a.m. to 9:00 a.m. and 2:30 p.m. to 4:30 p.m., Monday through Friday, as required Transportation Supervisor
More informationUNIVERSITY OF TOLEDO
UNIVERSITY OF TOLEDO SUBJECT: SHIPPING, PACKAGING AND RECEIPT OF Procedure No: HM-08-031 HAZARDOUS MATERIALS PROCEDURE Employees of the University of Toledo attempting to transport hazardous materials,
More informationPOLICY AND PROCEDURE JOB EVALUATION POLICY
POLICY AND PROCEDURE JOB EVALUATION POLICY Reference Number: 124 2007 Author / Manager Responsible: Peter Eley, HR Manager & AfC Project Manager Deadline for ratification: (Policy must be ratified within
More informationObjectives. The Regulatory Binder = Investigator Site File= Trial Center File 8/16/2010. Essential Documents: Maintaining the Site's Regulatory Binder
Essential Documents: Maintaining the Site's Regulatory Binder How to Manage the Essential Documents for the Investigator and Study Site Objectives Describe the importance of maintaining the Regulatory
More informationOctober 29, Comments on CPSIA Section 102: Requirements for Certificates for Conformity Testing and Third Party Testing
Mr. Todd A. Stevenson Secretary Consumer Product Safety Commission 4330 East-West Highway Room 502 Bethesda, MD 20814 Re: Comments on CPSIA Section 102: Requirements for Certificates for Conformity Testing
More informationH-20 Page 1 of 5. Institutional Review Board Policy Manual HUMANITARIAN USE DEVICE (HUD) REQUIREMENTS
H-20 Page 1 of 5 Institutional Review Board Policy Manual HUMANITARIAN USE DEVICE (HUD) REQUIREMENTS PURPOSE: To describe the requirements for McLeod Health IRB review of Humanitarian Use Devices (HUD).
More information